BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 1291024 · Received December 19, 2008

    Report

    Report Number
    1610287-2008-00050
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL; INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THERE HAVE BEEN NO OTHER REPORTS IN THIS LOT NUMBER. THE FACILITY WAS INFORMED THAT THEIR USE OF THIS PRODUCT MIXED WITH AIR AT 14% IN VITRECTOMY PROCEDURES WAS AN OFF-LABEL USE. ADDITIONAL INFO HAS BEEN REQUESTED BY FAX, MAIL AND BY PHONE ON 11/21/2008, 11/24/2008, 11/25/2008, 12/04/2008 AND 12/17/2008. THIS REPORT WAS MAILED TO FDA ON: 12/19/2008.

    Description of Event or Problem · 1

    A FACILITY REPORTED TWO PATIENTS EXPERIENCED ELEVATED INTRAOCULAR PRESSURES (IOP) FOLLOWING USE OF THIS PRODUCT. THE PRODUCT WAS REPORTED TO HAVE BEEN USED OFF LABEL; THE SURGEON MIXED 14% GAS WITH AIR FOR USE IN VITRECTOMY PROCEDURES. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ALCON LABORATORIES, INC. NA 713521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other